An observational study in Obesity and Overweight, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Observational
This observational study aims to investigate the impact of body composition on the absorption, distribution, and metabolism of anesthetic drugs, as well as on the incidence of complications in overweight and obese patients. The primary research question is whether specific body composition parameters in this population influence drug pharmacokinetics and complication rates. By integrating pharmacokinetic parameters, adverse drug reactions (ADRs), and clinical complications, the study will analyze variations in sufentanil kinetics under different body composition conditions. Under the guidance of research personnel, participants will undergo non-invasive body composition assessment using the nBody S10 analyzer. Key metrics collected will include, but are not limited to, mineral content, muscle mass, lean body mass (LBM), total body weight, and body fat percentage (BFP).
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 2,100 is above the median of 135 across 1,283 observational studies indexed under Obesity.
Browse Obesity studies →Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 133 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligible participants were adults aged 18 to 65 years with an ASA physical status of I-III and a body mass index (BMI) greater than 24 kg/m², who were scheduled to undergo surgery under general anesthesia.
Exclusion Criteria:
1: Severe organ dysfunction, including severe hepatic or renal insufficiency, unstable coronary syndrome, uncontrolled hypertension, and other severe cardiovascular diseases
2: History of chronic pain or long-term use of opioids/sedatives; preoperative use of potent CYP3A inhibitors or inducers
3: Contraindications to body composition measurement via Bioelectrical Impedance Analysis (BIA), including abdominal wall stoma, massive ascites, limb amputation/absence, and presence of cardiac pacemakers or implantable cardioverter-defibrillators (ICDs)
4: Women who were pregnant or breastfeeding were excluded from the study
5: Known hypersensitivity or allergy to study medications
6: Any other condition deemed by the investigator to make the patient unsuitable for participation, including but not limited to severe psychiatric disorders or legal restrictions
Patients aged 18 to 65 years, with ASA physical status I-III and a BMI \> 24 kg/m², undergoing surgery under general anesthesia.
control group
Plasma Drug Concentration
Determination of plasma sufentanil concentration by mass spectrometry during the perioperative period.
Time frame: Perioperative
Perioperative Complication Rate
including atelectasis, pneumonia, respiratory failure, reintubation, acute myocardial injury, intra-abdominal infection, reoperation, and death
Time frame: Up to 30 days postoperative
Fat percentage (%)
Fat percentage will be measured using the InBody S10 bioelectrical impedance analysis system
Time frame: Baseline and Postoperative Day 1
Weight
Body weight will be measured in kilograms using the InBody S10 body composition analyzer
Time frame: Baseline and Postoperative Day 1
Waist circumference
Waist circumference will be measured in centimeters using the InBody S10 analyzer
Time frame: Baseline and Postoperative Day 1
Plan to share: No — There is not a plan to make IPD available.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital of Wenzhou Medical University